Recognized standard
F1814-22
FDA recognition 11-395 · ASTM · Orthopedic
Key facts
| Recognition number | 11-395 |
|---|---|
| Designation | F1814-22 |
| Title | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety. 1.2 This guide does not attempt to define all test methods associated with modular device evaluation. 1.3 The disassembly… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: